A randomized trial of pegylated interferon α-2b plus ribavirin in the retreatment of chronic hepatitis C

American Journal of Gastroenterology

Volumn 100, Issue 11, 2005, Pages 2453-2462

  Jacobson, Ira M ^a   Gonzalez, Stevan A ^a   Ahmed, Furqaan ^a   Lebovics, Edward ^b   Min, Albert D ^c   Bodenheimer Jr , Henry C ^c   Esposito, Stephen P ^d   Brown Jr , Robert S ^e   Bräu, Norbert ^f   Klion, Franklin M ^g   Tobias, Hillel ^h   Bini, Edmund J ^f   Brodsky, Neil ⁱ   Cerulli, Maurice A ^j   Aytaman, Ayse ^f   Gardner, Peter W ^k   Geders, Jane M ^l   Spivack, Julie E ^m   Rahmin, Michael G ⁿ   Berman, David H ^o   Ehrlich, James ^p   Russo, Mark W ^a   Chait, Maxwell ^q   Rovner, Deborah ^a   Edlin, Brian R ^a   more..

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b NEW YORK MEDICAL COLLEGE   (United States)

^c BETH ISRAEL MEDICAL CENTER   (United States)

^d Hepatobiliary Associates of New York   (United States)

^e Columbia University College of Physicians and Surgeons ^*  (United States)

^f VETERANS AFFAIRS MEDICAL CENTER   (United States)

^g MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^h NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ Palmadessa and Kuan Gastroenterology Associates   (United States)

^j BROOKLYN HOSPITAL CENTER   (United States)

^k Gastroenterology Consultants   (United States)

^l NEW YORK METHODIST HOSPITAL   (United States)

^m Gastroenterology Associates of Fairfield County   (United States)

ⁿ Gastrointestinal Associates   (United States)

^o Gastroenterology Associates of Fairfield County ^*  (United States)

^p Gastroenterology of Westchester   (United States)

^q Hartsdale Medical Group   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN; PEGINTERFERON ALPHA2B; RIBAVIRIN; ALPHA2B INTERFERON; ANTIVIRUS AGENT; DRUG CARRIER; PEGINTERFERON ALFA-2B; VIRUS RNA;

ADULT; AFRICAN AMERICAN; ARTICLE; CAUCASIAN; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; GENOTYPE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SIDE EFFECT; TREATMENT OUTCOME; COMPARATIVE STUDY; DRUG COMBINATION; DRUG EFFECT; FOLLOW UP; GENETICS; HEPATITIS C VIRUS; MIDDLE AGED; RECURRENT DISEASE; RETREATMENT; VIROLOGY; VIRUS LOAD;

AFRICAN AMERICANS; ANTIVIRAL AGENTS; DRUG CARRIERS; DRUG COMBINATIONS; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; FOLLOW-UP STUDIES; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2B; MALE; MIDDLE AGED; RECURRENCE; RETREATMENT; RIBAVIRIN; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD;

EID: 33644646748     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2005.00282.x     Document Type: Article

References (51)

1. Marcellin P Pouteau M Boyer N, et al. Retreatment with recombinant interferon-alpha in patients with chronic hepatitis C. J Infect Dis 1993 167 : 780 1.
2. Alberti A Chemello L Noventa F, et al. Therapy of hepatitis C: Re-treatment with alpha interferon. Hepatology 1997 26 : 137S 142S.
3. Brillanti S Garson J Foli M, et al. A pilot study of combination therapy with ribavirin plus interferon alfa for interferon alfa-resistant chronic hepatitis C. Gastroenterology 1994 107 : 812 7.
4. Brillanti S Miglioli M Barbara L. Combination antiviral therapy with ribavirin and interferon alfa in interferon alfa relapsers and non-responders. J Hepatol 1995 23 ( suppl 2 S13 6.
5. Scotto G Fazio V Tantimonaco G. Pilot study of a short course of ribavirin and alpha interferon in the treatment of chronic active hepatitis C not responding to alpha-interferon alone. Ital J Gastroenterol 1996 28 : 505 11.
6. Bellobuono A Mondazzi L Tempini S, et al. Ribavirin and interferon-alpha combination therapy vs. interferon-alpha alone in the retreatment of chronic hepatitis C. J Viral Hepat 1997 4 : 185 91.
7. Toccaceli F Grimaldi M Rosati S, et al. Ribavirin plus human leucocyte interferon alpha for the treatment of interferon resistant chronic hepatitis C. Hepatol Res 1997 8 : 106 12.
8. Barbaro G Di Lorenzo G Soldini M, et al. Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone: An Italian multicenter, randomized, controlled, clinical study. Am J Gastroenterol 1998 93 : 2445 51.
9. Sostegni R Ghisetti V Pittaluga F, et al. Sequential versus concomitant administration of ribavirin and interferon alfa-n3 in patients with chronic hepatitis C not responding to interferon alone. Hepatology 1998 28 : 341 6.
10. Davis GL Esteban-Mur R Rustgi V, et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med 1998 339 : 1493 9.
11. Bell H Hellum K Harthug S, et al. Treatment with interferon-alpha2a alone or interferon-alpha2a plus ribavirin in patients with chronic hepatitis C previously treated with interferon-alpha2a. Scand J Gastroenterol 1999 34 : 194 8.
12. Barbaro G Di Lorenzo G Belloni G, et al. Interferon alpha-2B and ribavirin in combination for patients with chronic hepatitis C who failed to respond to, or relapsed after, interferon therapy: A randomized trial. Am J Med 1999 107 : 112 8.
13. Pol S Couzigou P Bourliere M, et al. A randomized trial of ribavirin and interferon-alfa vs. interferon-alfa alone in patients with chronic hepatitis C who were non-responders to a previous treatment. J Hepatol 1999 31 : 1 7.
14. Andreone P Gramenzi A Cursaro C, et al. Interferon-alpha plus ribavirin in chronic hepatitis C resistant to previous interferon alpha course. J Hepatol 1999 30 : 788 93.
15. Milella M Santantonio T Pietromatera G, et al. Retreatment of non-responder or relapser chronic hepatitis C patients with interferon plus ribavirin vs. interferon alone. Ital J Gastroenterol Hepatol 1999 31 : 211 15.
16. Salmeron J Ruiz-Extremera A Torres C, et al. Interferon versus ribavirin plus interferon in chronic hepatitis C previously resistant to interferon. Liver 1999 19 : 275 80.
17. Bresci G Parisi G Bertoni M, et al. Interferon plus ribavirin in chronic hepatitis C non-responders to recombinant alpha-interferon. J Viral Hepat 2000 7 : 75 8
18. Di Bisceglie AM Thompson J Smith-Wilkaitis N, et al. Combination of interferon and ribavirin in chronic hepatitis C: Re-treatment of nonresponders to interferon. Hepatology 2001 33 : 704 7
19. Saracco G Olivero A Ciancio A, et al. A randomized 4-arm multicenter study of interferon alfa-2b plus ribavirin in the treatment of patients with chronic hepatitis C relapsing after interferon monotherapy. Hepatology 2002 36 : 959 66.
20. Tassopoulos NC Tsantoulas D Raptopoulou M, et al. A randomized trial to assess the efficacy of interferon alpha in combination with ribavirin in the treatment of interferon alpha nonresponders with chronic hepatitis C: Superior efficacy of high daily dosage of interferon alpha in genotype 1. J Viral Hepat 2003 10 : 189 96.
21. Fargion S Bruno S Borzio M, et al. Sustained response to combination therapy in patients with chronic hepatitis C who failed to respond to interferon. J Hepatol 2003 38 : 499 505.
22. Cummings KJ Lee SM West ES, et al. Interferon and ribavirin vs. interferon alone in the re-treatment of chronic hepatitis C previously nonresponsive to interferon. JAMA 2001 285 : 193 9.
23. Cheng SJ Bonis PA Lau J, et al. Interferon and ribavirin for patients with chronic hepatitis C who did not respond to previous interferon therapy: A meta-analysis of controlled and uncontrolled trials. Hepatology 2001 33 : 231 40
24. Zeuzem S Feinman SV Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 2000 343 : 1666 72.
25. Heathcote EJ Shiffman ML Cooksley WG, et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 2000 343 : 1673 80.
26. Lindsay KL Trepo C Heintges T, et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001 34 : 395 403.
27. Reddy KR Wright TL Pockros PJ, et al. Efficacy and safety of pegylated (40-kd) interferon alpha-2a compared with interferon alpha-2a in noncirrhotic patients with chronic hepatitis C. Hepatology 2001 33 : 433 8.
28. Zeuzem S Welsch C Herrmann E. Pharmacokinetics of peginterferons. Semin Liver Dis 2003 23 ( suppl 1 23 8.
29. Manns MP McHutchison JG Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial. Lancet 2001 358 : 958 65.
30. Fried MW Shiffman ML Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002 347 : 975 82.
31. Shiffman ML Di Bisceglie AM Lindsay KL, et al. Peginterferon alfa-2a and ribavirin in patients which chronic hepatitis C who have failed prior treatment. Gastroenterology 2004 126 : 1015 23.
32. The French METAVIR Cooperative Study Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology 1994 20 : 15 20.
33. Bedossa P Poynard T. An algorithm for the grading of activity in chronic hepatitis C. Hepatology 1996 24 : 289 93.
34. Krawitt EL Lidofsky SD Ferrentino N, et al. Efficacy of peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C previously unresponsive to interferon-based therapy. Hepatology 2002 36 : 796A.
35. Lawitz EJ Bala NS Becker S et al. Pegylated interferon alfa-2b and ribavirin for hepatitis C patients who were nonresponders to previous therapy. Gastroenterology 2003 124 ( suppl 1 204.
36. Sulkowski M Rothstein K Stein L, et al. PEG-interferon alfa-2b and ribavirin for treatment of patients with chronic hepatitis C who have previously failed to achieve a sustained virological response following interferon or interferon alfa-2b and ribavirin therapy. Gastroenterology 2003 124 ( suppl 1 204.
37. Poynard T Schiff E Terg R, et al. Sustained virologic response (SVR) with PEG-interferon-alfa-2b/ribavirin weight based dosing in previous interferon/ribavirin HCV treatment failures; week 12 virology as a predictor of SVR in the EPIC3 trials. Gastroenterology 2005 128 : A681.
38. Reddy KR Hoofnagle JH Tong MJ, et al. Racial differences in responses to therapy with interferon in chronic hepatitis C. Hepatology 1999 30 : 787 93.
39. McHutchison JG Poynard T Pianko S, et al. The impact of interferon plus ribavirin on response to therapy in black patients with chronic hepatitis C. Gastroenterology 2000 119 : 1317 23.
40. Kinzie JL Naylor PH Nathani MG, et al. African Americans with genotype 1 treated with interferon for chronic hepatitis C have a lower end of treatment response than Caucasians. J Viral Hepat 2001 8 : 264 9.
41. Buti M Valdes A Sanchez-Avila F, et al. Extending combination therapy with peginterferon alfa-2b plus ribavirin for genotype 1 chronic hepatitis C late responders: A report of 9 cases (letter). Hepatology 2003 37 : 1226 7.
42. Shiffman ML Hofmann CM Gabbay J, et al. Treatment of chronic hepatitis C in patients who failed interferon monotherapy: Effects of higher doses of interferon and ribavirin combination therapy. Am J Gastroenterol 2000 95 : 2928 35.
43. Gross JB Therneau TM Johnson SM, et al. The RENEW trial: A national, multicenter study of high-dose peginterferon alfa-2b plus ribavirin for nonresponders with hepatitis C [Abstract 321]. 54th Annual Meeting of the American Association for the Study of Liver Diseases, October 24-28, 2003, Boston, MA. Hepatology 2003 38 ( suppl 1 312A.
44. Gross JB Johnson SM Therneau TM, et al. Double-dose peginterferon alfa-2b plus weight-based ribavirin for re-treatment of African-American non-responders with hepatitis C. Gastroenterology 2005 128 : A684.
45. Shiffman ML Hofmann CM Contos MJ, et al. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology 1999 117 : 1164 72.
46. Davis GL Wong JB McHutchison JG, et al. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 2003 38 : 645 52.
47. Zeuzem S Heathcote EJ Shiffman ML, et al. Twelve weeks of follow-up is sufficient for the determination of sustained virologic response in patients treated with interferon α for chronic hepatitis C. J Hepatol 2003 39 : 106 11.
48. Hadziyannis SJ Sette H Morgan TR, et al. Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C. Ann Intern Med 2004 140 : 346 55.
49. Jacobson I Brown R McCone J, et al. Weight based ribavirin dosing improves virologic response in HCV-infected genotype 1 African-Americans (AA) compared to flat dose ribavirin with peginterferon alfa-2b combination therapy. Hepatology 2004 40 ( 4, suppl 1 217A.
50. Shiffman ML Morgan TR Ghany MG, et al. The impact of peginterferon (PEGIFN) and ribavirin dosing on sustained virologic response (SVR) in patients with chronic hepatitis C virus (HCV) undergoing retreatment in the HALT-C Trial. Hepatology 2004 40 ( 4, suppl 1 314A.
51. McHutchison JG Manns M Patel K, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology 2002 123 : 1061 9.